Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Collaborator: AllerGen NCE Inc.

Criteria

Inclusion Criteria:

• Mild stable allergic asthma

• Positive skin-prick test to at least one common aeroallergen

• Positive methacholine challenge

• Positive allergen-induced early- and late-phase airway bronchoconstriction

• General good health

Exclusion Criteria:

• Lung diseases other than mild allergic asthma

• History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease

• Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium

• Use of tobacco products within one year starting study or smoking history >10 pack years

• If female, pregnant or lactating or have positive pregnancy test at screening